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Cancer Survivors3D-BONENCT07022262

Virtual Exercise Training and Its Impact on Bone Compartments in Adult Survivors of Childhood Cancer

A study testing Progressive resistance training plus impact loading in people with Cancer Survivors, run by Universidad de Granada at 1 site in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Childhood cancer is a rare disease but a significant cause of death in children and adolescents. The incidence of childhood cancer is 1case per 300 cases of adult cancer, but surviving to it has important sequels. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Cancer Survivors
What is being tested?
Progressive resistance training plus impact loading
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
1 siteSpain
Study dates
May 2026to Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Prior diagnosis of pediatric cancer and history of receiving treatment (radiation therapy and/or chemotherapy).
  • 18-55 years of age at recruitment

Who cannot join

  • Participation in another research study simultaneously.
  • Not currently receiving cancer treatment.
  • Previous diagnosed anorexia/bulimia, known pregnancy, known alcohol or drug abuse.
  • Requiring chronic oral glucocorticoid therapy.
  • Having an injury that may affect daily life activities and can be aggravated by exercise.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Esther Ubago Guisado, Ramón y Cajal researcher contact

+34 958246644

estherug@ugr.es

Luis Gracia Marco, Senior Lecturer contact

+34 958244363

lgracia@ugr.es

Spain1 site
  • Sport and Health University Research Institute (iMUDS), Technological Health Park, University of Granada

    Granada, Andalusia, 18007

    Esther Ubago Guisado, Ramón y Cajal researcher, +34 958246644, estherug@ugr.es

    Luis Gracia Marco, Senior Lecturer, +34 958244363, lgracia@ugr.es

Other trials in Spain

About this study

Official title: 3D-BONE: Virtual Exercise Training and Its Impact on Cortical and Trabecular Bone Compartments in Adult Survivors of Childhood Cancer: a Peripheral Quantitative Computed Tomography (pQCT) Study

Childhood cancer is a rare disease but a significant cause of death in children and adolescents. The incidence of childhood cancer is 1case per 300 cases of adult cancer, but surviving to it has important sequels. Endocrine dysfunction represents one of the most common issues in paediatric cancer survivors and impairs bone mineral density later in life. Some forms of exercise have been recommended to preserve bone health in healthy adults; however, its effect has not been properly studied yet in adult survivors of paediatric cancer using cutting-edge technologies, such as peripheral quantitative computed tomography (pQCT). As general aim, the 3D-BONE study will assess for the first time the effect of a live and online exercise programme on bone parameters and bone metabolism in adult survivors of paediatric cancer. This multicenter randomized controlled trial will be performed in three Andalusian provinces (Granada, Cordoba and Almeria). A minimum of 116 adult survivors of paediatric cancer aged 18 to 55 years will be recruited following the inclusion and exclusion criteria. They will be randomized (based on sex and age) into an INTERVENTION (n=58) or CONTROL group (n=58). The intervention group will receive a 6-month live and online exercise program based on progressive resistance and impact loading training that will be delivered by qualified professionals using a telehealth mobile app (3D-BONE app). Moreover, behaviour change techniques will be implemented in order to increase motivation and adherence to the program. This group will also receive diet counselling on calcium and vitamin so the difference between the groups is the exercise programme. Participants will be assessed before and after the intervention at the facilities of the Sport and Health University Research Institute (iMUDS) of the University of Granada. An in-depth analysis of bone parameters will be carried out using cutting-edge technologies, such as the pQCT (to analyse cortical and trabecular bone in 3 dimensions), dual-energy X-ray absorptiometry (DXA), hip and lumbar spine geometry outcomes. Moreover, a complete blood count will be obtained and markers of bone metabolism will be measured (B-CTX, PINP), including novel markers such as sclerostin and irisin which have recently been linked to human bone. Data will also be collected in anthropometry and body composition to obtain cardiovascular risk factors, sarcopenia and physiologic frailty risk factors, mental health, health-related quality of life and objective measures of physical activity and fitness. This will ensure obtaining novel, precise and strong data in this population.

Being tested
Progressive resistance training plus impact loading
Keywords
cancer survivors, childhood cancer, exercise, bone health, physical fitness, sarcopenia, physiological frailty, mental health, health-related quality of life, pQCT
Medical subject headings
Neoplasms, Motor Activity, Sarcopenia, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Progressive resistance training plus impact loadingBehavioural

    The intervention will be performed 3 days a week (Monday, Tuesday and Thursday [group 1] and Monday, Wednesday and Thursday [group 2]), following previous studies. Each section will last 45 minutes, comprising 10 minutes of warm-up, 20 minutes of resistance training, 10 minutes of impact exercises, and 5 minutes of cool down. There will always be a minimum of 24-hour interval between exercise sessions, and an extra training day (Friday) will be available if participants miss a training day in the respective week.

    The exercise periodisation will be composed by 3 phases (phase 1, phase 2 and phase 3). Across phases, training volume will vary and a progressively increase in exercise intensity will be applied in each phase. The three phases of the study will consist of 8 weeks, and within each phase the participants will perform six different training sessions.

Study groups in NCT07022262
Study groupRoleWhat they receive
Intervention groupExperimental6-months of live and online progressive resistance training plus impact loading + dietary counselling on calcium and vitamin D.
Receives: Behavioral: Progressive resistance training plus impact loading
Control groupNo interventionDietary counselling on calcium and vitamin D.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Cortical and Trabecular Volumetric Bone Mineral Density (pQCT)

    Cortical and trabecular BMD will be measured at tibia and radius using pQCT (mg/cm³).

    Measured: Baseline and 6 months

  2. Change in Cortical Bone Thickness (pQCT)

    Cortical bone thickness at tibia and radius (mm) will be derived from pQCT images.

    Measured: Baseline and 6 months

  3. Change in Periosteal and Endocortical Circumference (pQCT)

    Periosteal and endocortical circumference at tibia and radius will be measured via pQCT (mm)

    Measured: Baseline and 6 months

  4. Change in Cross-Sectional Moment of Inertia-CSMI (pQCT)

    CSMI at tibia and radius will be calculated to assess structural bone strength (mm⁴).

    Measured: Baseline and 6 months

  5. Change in Bone strehgth indices (pQCT)

    Bone strehgth indices at tibia and radius will be obtained from pQCT images

    Measured: Baseline and 6 months

  6. Change in Bone Mineral Content (DXA)

    BMC will be assessed using DXA at whole-body and regional sites (g)

    Measured: Baseline and 6 months

  7. Change in Areal Bone Mineral Density (DXA)

    Areal BMD will be measured with DXA at whole-body and regional sites (g/cm²)

    Measured: Baseline and 6 months

  8. Change in Cross-Sectional Area (DXA-HSA)

    Derived from hip structural analysis (mm²).

    Measured: Baseline and 6 months

  9. Change in Section Modulus (DXA-HSA)

    Indicates bone strength; calculated from HSA (mm³).

    Measured: Baseline and 6 months

  10. Change in Cross-Sectional Moment of Inertia (DXA-HSA)

    Assesses resistance to bending forces (mm⁴).

    Measured: Baseline and 6 months

  11. Change in Trabecular Bone Score (TBS)

    Lumbar spine texture will be assessed using TBS (TBS index).

    Measured: Baseline and 6 months

  12. Change in Serum Lipid Profile

    Cholesterol, triglycerides, HDL, LDL levels (mg/dL).

    Measured: Baseline and 6 months

  13. Change in Total bilirubin

    mg/dL

    Measured: Baseline and 6 months

  14. Change in Calcium

    mg/dL

    Measured: Baseline and 6 months

  15. Change in Creatinine

    mg/dL

    Measured: Baseline and 6 months

  16. Change in Phosphorus

    mg/dL

    Measured: Baseline and 6 months

  17. Change in Glucose

    mg/dL

    Measured: Baseline and 6 months

  18. Change in Magnesium

    mg/dL

    Measured: Baseline and 6 months

  19. Change in Uric acid

    mg/dL

    Measured: Baseline and 6 months

  20. Change in ALT/GPT

    U/L

    Measured: Baseline and 6 months

  21. Change in Na/K/Cl

    mEq/L

    Measured: Baseline and 6 months

  22. Change in Albumin

    g/dL

    Measured: Baseline and 6 months

  23. Change in Total protein

    g/dL

    Measured: Baseline and 6 months

  24. Change in Serum 25(OH) Vitamin D

    ng/mL

    Measured: Baseline and 6 months

  25. Change in Alkaline phosphatase

    U/L

    Measured: Baseline and 6 months

  26. Change in Bone specific alkaline phosphatase

    ng/mL

    Measured: Baseline and 6 months

  27. Change in Glycosylated hemoglobin

    mmol/mol

    Measured: Baseline and 6 months

  28. Change in Parathyrin

    pg/mL

    Measured: Baseline and 6 months

  29. Change in Thyrotropin

    µUI/mL

    Measured: Baseline and 6 months

  30. Change in Gamma-glutamyl transferase

    U/L

    Measured: Baseline and 6 months

  31. Change in β-CTX (Serum)

    Marker of bone resorption (ng/mL)

    Measured: Baseline and 6 months

  32. Change in PINP (Serum)

    Marker of bone formation (ng/mL)

    Measured: Baseline and 6 months

  33. Change in Irisin (Serum)

    ng/mL

    Measured: Baseline and 6 months

  34. Change in Sclerostin (Serum)

    ng/mL

    Measured: Baseline and 6 months

Secondary outcomes (27)
  1. Change in Body Mass

    Measured with electronic scale (kg).

    Measured: Baseline and 6 months

  2. Change in Height

    Measured with stadiometer (cm).

    Measured: Baseline and 6 months

  3. Change in Body Mass Index (BMI)

    Calculated as kg/m².

    Measured: Baseline and 6 months

  4. Change in Blood Pressure

    Systolic and diastolic pressure measured in mmHg.

    Measured: Baseline and 6 months

  5. Change in body circumferences

    Waist, hip and neck circumferences measured in cm.

    Measured: Baseline and 6 months

  6. Change in Lean Soft Tissue Mass (DXA)

    Assessed at whole-body using DXA (g).

    Measured: Baseline and 6 months

  7. Change in Fat Mass (DXA)

    Assessed at whole-body using DXA (kg).

    Measured: Baseline and 6 months

  8. Change in Body Fat Percentage (DXA)

    Assessed at whole-body using DXA (%).

    Measured: Baseline and 6 months

  9. Change in 6-Minute Walk Test

    Distance walked in 6 minutes (meters).

    Measured: Baseline and 6 months

  10. Change in Squat Jump Test

    Height achieved in the test (cm).

    Measured: Baseline and 6 months

  11. Change in Handgrip Strength Test

    Maximal grip force (kg).

    Measured: Baseline and 6 months

  12. Change in Standing Long Jump Test

    Distance achieved in the test (cm).

    Measured: Baseline and 6 months

  13. Change in 5 Times Sit-to-Stand Test

    Time to complete 5 repetitions (seconds)

    Measured: Baseline and 6 months

  14. Change in 4-m Gait Speed Test

    Time to walk 4 meters (seconds)

    Measured: Baseline and 6 months

  15. Change in Self-Reported Fitness (IFIS)

    Perceived fitness using IFIS questionnaire.

    Measured: Baseline and 6 months

  16. Change in Sarcopenia Classification (EWGSOP2)

    Sarcopenia will be classified as no, probable, or confirmed based on grip strength, sit-to-stand time, and appendicular lean mass by DXA. Categorical (no/probable/confirmed).

    Measured: Baseline and 6 months

  17. Change in Frailty Status

    Frailty will be assessed using five criteria: low muscle mass, fatigue, low physical activity, slowness, and weakness. Categorical (frail/non-frail).

    Measured: Baseline and 6 months

  18. Change in Physical Activity and Sedentarism (Accelerometer)

    Measured over 7 consecutive days using ActiGraph (counts per minute).

    Measured: Baseline and 6 months

  19. Change in Self-Reported Physical Activity (IPAQ)

    Activity levels using the IPAQ (MET-min/week)

    Measured: Baseline and 6 months

  20. Change in Bone-Specific Physical Activity (BPAQ)

    Scored from the BPAQ questionnaire (BPAQ score)

    Measured: Baseline and 6 months

  21. Change in Calcium Intake

    Estimated using validated short calcium questionnaire (mg/day).

    Measured: Baseline and 6 months

  22. Change in Vitamin D Intake

    Estimated from dietary questionnaire (IU/day).

    Measured: Baseline and 6 months

  23. Change in Mediterranean Diet Adherence

    Calculated from validated adherence questionnaire (Score 0-14)

    Measured: Baseline and 6 months

  24. Change in Quality of Life

    HRQoL from the SF-36 questionnaire (0-100 scale).

    Measured: Baseline and 6 months

  25. Change in Anxiety and Depression (HADS)

    Anxiety and depression score from HADS (Score 0-21)

    Measured: Baseline and 6 months

  26. Change in Self-Esteem (Rosenberg Scale)

    Assessed using Rosenberg Self-Esteem Scale (Score 0-30)

    Measured: Baseline and 6 months

  27. Change in Perceived Stress (PSS)

    Assessed via Perceived Stress Scale (Score 0-40).

    Measured: Baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2025
  2. Study startMay 2026 (estimated)
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
116 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07022262
Sponsor's protocol ID
Universidad de Granada
Other IDs
PID2023-150311OB-I00
Acronym
3D-BONE
Status last verified
Apr 2026
First submitted
26 May 2025
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data files including IPD and corresponding data dictionaries will be shared under restricted access and upon reasonable request (E Ubago-Guisado or L Gracia-Marco) due to privacy issue and GDPR regulations. In principle, all collected IPD will be available for sharing under the "as open as possible, as closed as necessary" principle. The shared data files will be pseudonymized, only include participants who provided informed consent for sharing, and sharing is only possible when the data is used for research purposes. This is stated at the informed consent files that the participants signed when they agree to participate.

Questions about this trial

What is this clinical trial studying?

A study testing Progressive resistance training plus impact loading in people with Cancer Survivors, run by Universidad de Granada at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Esther Ubago Guisado, Ramón y Cajal researcher (+34 958246644, estherug@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Cortical and Trabecular Volumetric Bone Mineral Density (pQCT) (time frame: Baseline and 6 months). The study lists 34 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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